6.3 Planning of change

GENERAL POLICY

As situations arise that demand changes to the quality management system either to meet objectives or because of changing business conditions, all changes will be reviewed by the Top Management team to ensure the integrity of the quality system is maintained.

Quality objectives are established to support and implement the quality policy and continual improvement. Quality planning includes identification and determination of quality system processes (including any exclusions of ISO 9001:2015 requirements); priorities for continual improvement; and resources needed to achieve quality objectives and to maintain and improve the quality system. Quality plans are periodically reviewed and updated to maintain the integrity of the quality system during organizational and other changes.

PROCEDURAL POLICIES

1. Quality system planning

1.1 Quality system elements and processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is:

To achieve the quality policy;

To ensure and demonstrate our ability to provide consistent product and services that meets customer and regulatory requirements;

To ensure high level of customer satisfaction;

To facilitate continual improvement; and

To comply with requirements of ISO 9001:2015 standard.

1.2 The output of quality system planning is documented in this quality manual, in associated operational procedures, and in other referenced documents. These documents identify and define all elements and processes of the quality system.

1.3 Changes to the quality system or processes or organization are planned within the framework of management review.  These changes may be in response to changing circumstances, such as product, process, capacity, or other operational or organizational change; or to improve the effectiveness and efficiency of the quality system.

1.4 Top level management reviews changes to the integrity of the quality system.  IQA’s validate the integrity of the system.   We also do control tests on smaller scales when deemed necessary.

1.5 Harrington reviews the availability of resources and allocation / re-allocation of resources by acquiring and analyzing data for tact time data for assembly, manufacturing, distribution, corrective actions, etc.  Since we know how long everything takes, we can calculate what the planned changes impacts will be.

 

Revision History:

Revision Date Description of Changes Approved By
0.0 07/03/17 Initial Release Jim Theesfeld
1.0 8/17/18 Digitized version Todd Gifford